Kornimate/medical-research-clean huggingface dataset:
comparison in the treatment of acute cystitis using cephalosporin and norfloxacin (ceci)

Conditions: Cystitis

Summary: this study is to assess if the efficacy of cephalosporin is similar to the efficacy of norfloxacin in the acute cystitis treatment.


Eligibility criteria:
inclusion criteria: * sign, initialize and date the informed consent form * age ≥ 18 years * for urinary infection diagnosis, the following parameters must be considered in the urine i test: * leukocyturia: ≥ 15,000 leukocytes * epidermal cells: \< 20,000/ml * presence of bacteriuria * presence of nitrite (positive results) * to have a 2 points score (from 12 points) regarding the following symptoms of acute cystitis: * dysuria * urinary urgency * frequent urination * pain in the upper area of pubis each symptom must be scored according to the classification below. total score may range from 0 to 12 points. severity value absent 0 mild 1 moderate 2 severe 3 exclusion criteria: research subjects that meet any of the criteria below will not be eligible for the study: * asymptomatic urinary infection or infection in any organ * documented incidence of uti in the last year * symptoms of pyelonephritis (cystitis symptoms plus fever, lower back pain or chills) * history of complicated urinary tract infection (congenital abnormalities, urinary tract distortion or obstruction, formation of calculus in the urinary tract) * use of catheter in the urinary tract * chronic renal or hepatic disease * seizure-related diseases * neurological deficits that interfere in the urinary flow and tract defense * decompensated diabetes mellitus (fasting blood glucose ≥ 150 mg/dl); * immunodepression: * subjects with the human immunodeficiency virus (hiv) * chronic use of corticosteroids in a dose ≥ 5 mg/day of prednisone for over 30 days * any diseases related to immune dysfunction * severe comorbidities (at the investigator's discretion) * history of allergy to penicillins, cephalosporines or quinolones * subjects on medications such as antibiotics, amiodarone, antacids or sucralphate, tricyclic antidepressants, antipsychotics, cyclosporine, cisapride, didanosine, erythromycin, fembufeno, gliburide (a sulphonilurea), nitrofurantoin, probenecid, procainamide, quinidine, sotalol, teophylline, warfarin * treatment due to uti two weeks before entering study, or on antimicrobial treatment at least 3 times within the last 12 months * use of phenazopyridine 7 days before entering the study * hospitalization 30 days before study enrollment * female research subjects that are pregnant, breastfeeding, or women with childbearing potential that deny to use at least two safe contraceptive methods during study * participation in another clinical trial in the last 12 months

Keywords: acute cystitis
epsilon-aminocaproaic acid to reduce the need for blood transfusions during and following spine surgery

Conditions: Scoliosis; Kyphosis; Lordosis; Spondylitis; Spinal Stenosis

Summary: individuals who undergo spine surgery often have a significant loss of blood and may require multiple blood transfusions. research has shown that epsilon-aminocaproic acid (eaca) may reduce the amount of blood lost during surgery, which would decrease the number of blood transfusions required. this study will evaluate the safety and effectiveness of eaca at reducing blood loss and the need for blood transfusions in individuals undergoing spine surgery.

spine surgery is often required to correct a number of diseases, including spondylosis, pseudoarthrosis, scoliosis, or other spinal deformities. spine surgery is often associated with significant blood loss and individuals may require multiple blood transfusions during and following surgery. blood transfusions are expensive and carry an increased risk of health complications, including fever, allergic reactions, or infections. preliminary research has shown that eaca may be beneficial for individuals undergoing spine surgery. in addition, eaca appears to be safer and less expensive than other medications typically used to treat serious bleeding. the purpose of this study is to evaluate the safety and effectiveness of eaca at reducing the number of blood transfusions required during and following spine surgery in adults. this study will enroll individuals who are undergoing spine surgery at johns hopkins hospital. prior to surgery, participants' demographic data and medical history will be collected. participants will then be randomly assigned to receive either eaca or placebo intravenously during surgery and for 8 hours following surgery in the intensive care unit (icu). while in the hospital, participants will have blood drawn frequently for laboratory testing. they will receive blood transfusions as needed and will be closely monitored for blood loss and any medical, surgical, or transfusion complications. outcome measurements related to the amount of transfused blood required and postoperative complications will be collected on the 8th day following surgery. study participation will end on the day of hospital discharge or the day of a necessary second surgery.

Eligibility criteria:
inclusion criteria: * diagnosis of spondylosis, pseudoarthrosis, kyphoscoliosis, or acquired or congenital spine deformity * willing to undergo elective spinal surgery by a participating surgeon; eligible procedures include the following: spine osteotomy, arthrodesis, instrumentation and/or corpectomy, surgery for lumbar spinal stenosis, or surgery for degenerative disc disease exclusion criteria: * requires urgent or emergent surgery * has kidney failure that requires dialysis * has a known bleeding diathesis, defined as a documented history of an inherited bleeding disorder (e.g., hemophilia or von willebrand's disease) or prothrombin time ratio greater than 1.5 seconds or a documented previous arterial or venous thrombosis within 1 year of study entry * pregnant

Keywords: aminocaproic acids blood transfusion
safety and performance of swis in superficial wounds

Conditions: Wound of Skin

Summary: this is an open, evaluator blinded, intra-comparative, randomized, non-inferiority investigation prior to ce mark to confirm safety and performance of the swis device when used as intended, i.e. as an irrigation solution for mechanical rinsing of breached or compromised skin as a result from acute wounds.


Eligibility criteria:
inclusion criteria: * healthy and intact skin where the blister suction wounds will be induced * been informed of the nature, the scope and the relevance of the clinical investigation * voluntarily agreed to participation and has duly signed the information consent form exclusion criteria: 1. participating in any other clinical investigation 2. disease that may interfere with the wound healing, e.g. diabetes, arterial-, renal-, liver, or cardiac insufficiency, chronic obstructive lung disease, cancer, autoimmune disease, edema of the arm, severe obesity, severe psychiatric disease, dementia or previous known wound healing problems, as judged by the investigator 3. active skin disease, e.g. dermatitis, psoriasis and wounds, and/or tattoos in the areas where suction blister wounds will be induced, as judged by the investigator 4. daily smoker 5. pregnancy 6. systemic immunosuppressive treatment 7. uncontrolled pain that may interfere with the investigation outcome, as judged by the investigator 8. allergy to hypochlorous acid, acetic acid or any other remedies/material used in the clinical investigation 9. not able to read or understand danish 10. any other conditions that as judged by the investigator may make follow-up or investigation inappropriate 11. that according to the declaration of helsinki is deemed unsuitable for study enrolment
68ga-pmd22 pet/ct examination targeting cldn18.2

Conditions: Gastrointestinal Cancer

Summary: to investigate the ability of the cldn18.2-targeted 68ga-pmd22 tracer to detect cldn18.2 expression in patients with gastric and colorectal cancer and other gastrointestinal tumours.

the 2016 fast study brought a "new star" target for gastric cancer - cldn18.2 (claudin 18 splice variant 2,cldn18.2), which belongs to the cldn family of tight junction proteins and is involved in the formation of paracellular tight junctions and maintenance of cell polarity. cldn18.2 is mainly found in the normal gastric mucosa (normal gastric glands, principal cells, mural cells, endocrine cells) where the differentiation cycle is short and renewal is rapid, and in the duodenal panniculocytes, but not in the gastric stem cell region. it is now generally accepted that cldn18.2 is expressed in normal gastric tissue confined to the tight junctions at the outer base of the gastric mucosal cells, whereas tumours undergo a change in cell polarity during malignant transformation, resulting in widespread exposure of cldn18.2 to the cell membrane surface. the cldn18.2 gene is also aberrantly activated and highly specific and stably expressed in specific tumour tissues, participating in the proliferation, differentiation and migration of tumour cells, making it a potentially effective target for anti-tumour drugs. in this study, a molecular probe pmd22 targeting cldn18.2 was synthesised in a previous study and a 68ga-pmd22 injection was developed for clinical trials. the preliminary study showed that the tracer has good safety and good imaging effect. it is proposed to further conduct exploratory pet/ct imaging studies on patients with gastric cancer, colorectal cancer and other gastrointestinal tumours, to provide a new technique for in vivo, non-invasive and visual detection of cldn18.2 expression level and spatial distribution for patients with gastric cancer, colorectal cancer and other gastrointestinal tumours, and to validate its clinical application value for the diagnosis of gastric cancer, colorectal cancer and other gastrointestinal tumours.

Eligibility criteria:
inclusion criteria: * in the near future (within 2 months), patients who plan to undergo puncture biopsy or undergo tumor surgical treatment or are clinically highly suspected of cancer (including primary and tumor recurrence and metastasis) * able to understand and voluntarily sign informed consent forms, with good compliance exclusion criteria: * severe abnormalities in liver and kidney function * suffering from claustrophobia or other mental illnesses * pregnant and lactating women

Keywords: cldn18.2 gastric cancer colorectal cancer positron emission tomography
the 90% effective flow of high flow nasal oxygenation (hfno) during sedated bronchoscopy

Conditions: Hypoxia

Summary: patients undergoing sedated bronchoscopy were randomized into six groups (10 liters/minute \[l/min\], 20 l/min, 30 l/min, 40 l/min, 50 l/min, 60 l/min). the primary outcome was the incidence of hypoxemia.

it's a double-blind, randomized trial. the patients'demographic information, such as sex, weight, height, smoking status, present illness and history of past illness, were collected. after successful peripheral intravenous access, all patients, before sedation, received 20 min nebulization with lidocaine via a nebuliser facemask. the basic oxygen saturation, heart rate, and blood pressure of the patients were recorded by the investigators.patients in the hfno group received humidified oxygen at different rates via a high-flow nasal cannula (airvo2, new zealand). after sedation with propofol and sufentanil, continuous electrocardiography and pulse oximetry were recorded, and the blood pressure of the patients was monitored throughout the procedure. . after bronchoscopy, patients were transferred to the post anesthesia care unit (pacu) if their vital signs were stable.

Eligibility criteria:
inclusion criteria: * (1) undergoing sedated bronchoscopy * (2) 18 to 70 years of age; * (3) american society of anaesthesiologists (asa) class: i-iii exclusion criteria: * (1) severe cardiac disease, including aortic stenosis, mitral stenosis, hemodynamic instability caused by severe arrhythmia, and acute myocardial infarction or cardiac surgery within the last 6 months; * (2) severe hypoxemia (spo2 \< 90% without oxygen supply on admission), caused by interstitial lung disease, end-stage chronic obstructive pulmonary disease (copd) or other diseases; * (3) upper respiratory tract infection or lung infection; * (4) refusal to participate in this study.

Keywords: high flow nasal oxygenation hypoxemia bronchoscopy effective flow
contrast-enhanced digital mammography (cedm) for identifying a change in management of women with newly diagnosed breast cancer

Conditions: Breast Cancer

Summary: enrolled women will undergo a bilateral contrast-enhanced breast magnetic resonance imaging (ce-bmri) as per usual clinical practice within 30 days of breast cancer diagnosis. up to 8 weeks after the ce-bmri exam, subjects will undergo a dual energy contrast enhanced digital mammograph (de-cedm).

enrolled women will undergo a bilateral contrast-enhanced breast magnetic resonance imaging (ce-bmri) as per usual clinical practice within 30 days of breast cancer diagnosis. up to 8 weeks after the ce-bmri exam, subjects will undergo a dual energy contrast enhanced digital mammograph (de-cedm). maximum lesion size was compared between the two imaging types. subject data from both scans was planned to be included in a multi-reader evaluation; however, due to premature stop of the study, multi-reader data was not collected.

Eligibility criteria:
inclusion criteria: * woman 21 years of age or older * the subject is able and willing to comply with study procedures and signed and dated informed consent is obtained. * newly diagnosed with breast cancer (dcis or invasive) identified through core biopsy or fine-needle aspiration (fna) within last 30 days. * will have or have had a bilateral ce-bmri performed within 30 days after the new breast cancer diagnosis. exclusion criteria: * woman who has already had a lumpectomy for the index lesion. * woman undergoing neoadjuvant chemotherapy treatment, hormone treatment or radiation therapy. * woman who is pregnant or who believe she may be pregnant. * woman who has breast implant. * woman who has a contraindication to the intravenous use of iodinated or gadolinium-chelated contrast agent (e.g., allergy to either agent or severely impaired renal function).

Keywords: mammography
a safety, tolerability and preliminary efficacy study of frtx-02 capsules in healthy subjects and subjects with atopic dermatitis

Conditions: Atopic Dermatitis Eczema

Summary: frtx-02 is an orally-available, potent and selective dyrk1a inhibitor.

this is a randomized, placebo controlled, double blind study in healthy subjects and subjects with atopic dermatitis that is designed to assess the safety and tolerability of frtx-02 capsules at single and multiple ascending doses. safety will be assessed through vital signs, ecg, adverse events and safety laboratory tests. pharmacokinetic and pharmacodynamic information will also be collected.

Eligibility criteria:
selected inclusion criteria part 1 (sad/mad) * healthy male or female * 18-55 years of age, inclusive * at least 50 kg in weight (males) and 45 kg in weight (females) * bmi 18.5-30.0 kg/m2, inclusive part 2 (subjects with ad) * male or female with atopic dermatitis * 18-65 years of age, inclusive * bmi 18-40.0 kg/m2, inclusive * validated investigator's global assessment (viga-ad) score of ≥ 3 (moderate) * body surface area (bsa) with ad involvement ≥ 10% * history of inadequate response to treatment with topical medications (e.g., corticosteroids, calcineurin inhibitors, etc.) or subjects for whom topical treatments are otherwise medically inadvisable. selected exclusion criteria part 1 (sad/mad) * use of tobacco products within 3 months prior to drug administration * history of alcohol abuse or drug abuse * positive urine drug screen, alcohol breath test, or urine cotinine test * participation in a clinical research study involving the administration of an investigational or marketed drug within 30 days prior to drug administration * donation of plasma within 7 days prior to dosing or donation or loss of 500 ml or more of whole blood within 8 weeks prior to dosing. part 2 (subjects with ad) * history of alcohol abuse or drug abuse * positive urine drug screen, alcohol breath test, or urine cotinine test * participation in a clinical research study involving the administration of an investigational or marketed drug within 12 weeks prior to drug administration
correlation of vitamin d levels in early pregnancy with gestational diabetes and pregnancy outcomes

Conditions: GDM

Summary: explore the specific correlation between different concentration levels of vitamin d in early pregnancy and blood glucose levels at each time node of ogtt, the correlation between different concentrations of vitamin d levels and a1 and a2 diabetes in pregnancy, and the impact on maternal and infant outcomes , and provide a basis for the prevention and treatment of gdm.

1. according to the diagnostic criteria of gdm proposed by the international association for the study of diabetes and pregnancy (iadpsg), the 18-45-year-old pregnant women who were filed and delivered by the obstetrics department of beijing friendship hospital from september 2022 to september 2024 were selected to collect their early pregnancy (pregnancy 1- 3 months) vitamin d level, divided into three groups: a (\<20 ng/ml), b (20\~\<30 ng/ml), and c (≥30 ng/ml), compare the early pregnancy (1-3 months of pregnancy) differences in vitamin d levels. 2. follow-up patients with gestational diabetes mellitus are divided into type a1 gestational diabetes patients (gdm 1 group) and type a2 gestational diabetes patients (gdm 2 group) according to whether participant are treated with insulin, and study vitamins through multiple linear and logistic regression models the relationship between d level and gdm and follow-up pregnancy outcome 3. analyze the relationship between the level of vitamin d in early pregnancy and pregnancy complications, such as whether it is combined with premature rupture of membranes, hypertension during pregnancy, whether it is a cesarean section, whether it is a giant baby, whether there is asphyxia in newborns, etc.

Eligibility criteria:
inclusion criteria: pregnant women aged 18 to 45 years who have received regular antenatal examinations and delivered in the department of obstetrics in beijing friendship hospital, capital medical university. exclusion criteria: (1) chronic or acute disease history (diabetes mellitus, hypertension,or thyroid disease); (2) any mental disorder; (3) abortion (fetal loss before 28 gestational weeks); (4)multiple fetuses; (5) planning to give birth in other hospitals.
safety analysis of intravenous rapid infusion of obinutuzumab in patients with b-cell non-hodgkin's lymphoma in china

Conditions: Obinutuzumab; Rapid Infusion; Intravenous Infusion Reaction

Summary: this study aimed to analyze the safety of 90-min intravenous rapid infusion of obinutuzumab in patients with b-cell non-hodgkin's lymphoma and to provide evidence for the applicability of rapid infusion regimens in chemotherapy in china.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of b-cell lymphoma and with indications for obinutuzumab treatment * no significant organ damage * ecog score of 0-2; * life expectancy ≥ 6 months * informed consent exclusion criteria: * pregnant or lactating * serologically tested positive for human immunodeficiency virus or hepatitis b virus infection but had not received treatment * severe hepatic or renal insufficiency * severe cardiovascular disease.
prophesys 3: observational study on predictors of response in patients with treatment-naïve chronic hepatitis c initiated on treatment with pegasys (peginterferon alfa-2a) or peginterferon-alfa-2b

Conditions: Hepatitis C, Chronic

Summary: this observational study will assess predictors of early on-treatment and sustained virological response in treatment-naïve patients with chronic hepatitis c initiated on treatment with pegasys (peginterferon alfa-2a) or peginterferon alfa-2b and ribavirin. data will be collected during the treatment period (24 or 48 weeks) and 12 and 24 weeks after the end of treatment. target sample size is \<2000.


Eligibility criteria:
inclusion criteria: * adult patients, \>/= 18 years of age * chronic hepatitis c * hiv hcv co-infection allowed * informed consent to data collection exclusion criteria: * co-infection with hepatitis b virus (hbv) * previous treatment with peginterferon and/or ribavirin
impact of intermittent hypoxia on the function of the phagocytes

Conditions: Obstructive Sleep Apnea of Adult

Summary: patients with treatment-naive obstructive sleep apnea (osa) who need continuous positive airway pressure (cpap) therapy on clinical basis are included as well as healthy controls without osa. 15 cc peripheral venous blood is drawn on the date of diagnosis of osa and 3-6 months after cpap therapy. granulocytes are harvested and tested for its function, such as phagocytosis, reactive oxygen species (ros) production and bacteria-killing ability.

patients with treatment-naive obstructive sleep apnea (osa) who need continuous positive airway pressure (cpap) therapy on clinical basis are included. healthy controls without osa are enrolled, too. 15 cc peripheral venous blood is drawn on the date of diagnosis of osa and 3-6 months after cpap therapy (not given to controls). granulocytes are harvested and tested for its function, such as phagocytosis, reactive oxygen species (ros) production and bacteria-killing ability.

Eligibility criteria:
inclusion criteria: \ 1. patients with treatment-naive obstructive sleep apnea (osa) who need continuous positive airway pressure (cpap) therapy on clinical basis 2. aged 20 years or older 3. apnea-hypopnea index (ahi) at least 15/hour 4. willing to participate this study \ 1. healthy controls without osa 2. aged 20 years or older 3. ahi less than 5/hour exclusion criteria: \ 1. osa patients who do not need continuous positive airway pressure (cpap) therapy 2. osa patients have ever received cpap or other treatment 3. aged less than 20 years 4. ahi at least 15/hour 5. not willing to participate this study \ 1. apnea-hypopnea index (ahi) equals to or more than 5/hour 2. aged less than 20 years 3. not willing to participate this study

Keywords: obstructive sleep apnea intermittent hypoxia granulocyte function continuous positive airway pressure (cpap) therapy